The European Commission kicked off 2023 with the green light for a series of novel foods on protein from mushrooms, rice and peas, insects, and milk. As well as some oligosaccharides identical to those found in breast milk. A brief review of the novel foods authorized in the EU follows.
1) MUSHROOMS.
1.1) Protein from peas and rice, fermented by shiitake mushroom
Shiitake, Lentinula edodes, is prominent in the cultivation and consumption of mushrooms (fresh and dried) in Asian tradition. From Thailand to China to Korea and Japan. The US group MycoTechnology Inc. used it in the fermentation of pea and rice concentrates, which were then spray-dried to obtain a fine powder(FermentIQ™). High in vegetable protein (> 75%) and allergen-free. (1)
The historicity of use of raw materials has not made it necessary to investigate toxicological and allergenic aspects in depth. On the other hand, traditional food status in the EU was only granted to the whole Shiitake mushroom and not also to the dried and dehydrated ones. Authorization is granted with exclusivity, for use in a myriad of foods. Baked goods, beverages, soups, meats, meat substitutes(as already other mycoproteins), meal replacements, etc., at even significant concentrations.(2)
1.2) Antrodia camphorata powder.
Antrodia camphorata
is the fungus also known as ‘niu-chang-chih,’ or Taiwanofungus camphoratus. It is used in traditional Chinese medicine but also (mycelia and fruiting bodies) as an ingredient in various foods and beverages.
Golden Biotechnology Corp.
has applied for its authorization without exclusivity for use in dietary supplements only. (3) With favorable outcome for products intended for individuals aged > 14 years, in the absence of safety data for infants and children. (4)
1.3) Champignon mushroom powder containing vitamin D2
Monterey Mushrooms Inc.
has received exclusive approval to market a mushroom mushroom(Agaricus bisporus) powder made by dehydrating and grinding the UV-irradiated product. (5)
The product is intended for a variety of conventional foods (e.g., dairy, soft drinks), as well as for dietary supplements and dieto-therapeutic foods (meal replacements for weight control, daily ration substitutes, and foods for special medical purposes. EU Reg. 609/2013).
Infants (0-12 months) and toddlers (1-3 years) were excluded en route, partly because of some concerns about vitamin D exposure, which has been greatly increased by theexploitation of related supplements, according to EFSA’s opinion. (6)
1.4) Agaricus bisporus mushrooms. Novel foods or trivial exclusives on traditional foods?
Champignon mushrooms(Agaricus bisporus) have been cultivated in Europe for several hundred years. Nonetheless, the European Commission has already granted four exclusive marketing authorizations for this ‘novel food,’ whose ‘disruptive innovation‘ compared to other foods already on the market is doubtful.
More attention should therefore be paid-both when implementing reg. EU 2015/2283, both in its revision – to inhibit the instrumental use of the novel food authorization procedure with five-year exclusivity in favor of the applicant on the street, to protect innovations not suitable for industrial patenting (see also the case of Eat Just’s so-called vegetable egg).
2) INSECTS.
2.1) Domestic cricket
Domestic cricket(Acheta domesticus) has already received approval as a novel food in early 2022, as noted. This year alone, however, the news has garnered populist reactions inspired by neophobia.
No substantial changes in this second authorization of crickets as novel food-again, with exclusivity in favor of the applicant-in the form of degrassed powder. Under conditions of use, by the way, very small (1-5%). (5) No gastronomic ‘threat’ in sight.
Cricket protein moreover, where taken as an alternative to red meat protein, could improve the life and health expectations of populations. In addition to decreasing the number of Disability-Adjusted Life Years(DALYs) lost in disabling diseases, as already shown in the NovRBA research project.
2.2) Alfithium
Alphitobius diaperinus
, known as the lesser mealworm, is a larva that develops into a beetle. Hitherto regarded as a pest of grains and foodstuffs, it can in turn be enhanced as food. And it has already been evaluated as safe, as well as nutritious, by the European Food Safety Authority (EFSA).
Ynsect NL B.V.
has been granted exclusive permission to market it as a novel food in dried, powdered, paste or frozen and freeze-dried forms. Use as an ingredient in breads, pastas, pizzas, soups, snacks and other foods has no age restrictions. Conversely, use in dietary supplements has been restricted to an adult audience (>18 years), at the applicant’s choice. (6)
3) PROTEIN FROM MILK
Arla Foods Ingredients Group P/S has obtained authorization with exclusivity to place on the EU market a β-lactoglobulin (BLG) isolate from cow’s whey, dried by spray-drying. The novel food (≥ 90% dry matter protein) consists of BLG as the primary component (≥ 90% of total protein), equivalent to BLG found in bovine milk and whey protein isolate.
What is new is the process of separation by crystallization under acidic or neutral conditions. The product is not indicated in cases of allergies to soy (as well as milk and soy, due to lecithin involves potential allergenicities, including from the use of soy lecithin used as an emulsifier. (9)
The novel food is authorized for use in soft drinks, including milk-based, whey powder (reconstituted) and foods for special medical purposes. (10)
4) OLIGOSACCHARIDES
Some oligosaccharides identical to those found in human milk (HiMO, Human identical Milk Oligosaccharides) have also been authorized as novel foods in recent months.
4.1) Lacto-N-tetraose
Lacto-N-tetraose is a HiMO that Chr. Hansen A/S obtained from two genetically modified strains of Escherichia coli BL21 (DE3). The same sugar, produced by the K-12 strain of E.Coli, has already been approved as a novel food. And the same strain has itself already been licensed to produce other HiMOs, lacto-N-neotetraose and 2′-fucosyllactose. (11)
The novel food authorization granted with exclusivity provides for the use of lacto-N-tetraose in:
- Infant and follow-on formulas,
- cereal-based foods and early childhood foods,
- Milk drinks and early childhood analogs,
- Foods for special medical purposes (for infants, children and others),
- dietary supplements. The latter cannot be given to children under 3 years of age or be given on the same day where other lacto-N-tetraose foods are contributed. (12)
4.2) 3-fucosyllactose
3-Fucosyllactose is another HiMO produced by fermentation of the genetically modified Escherichia coli BL21 (DE3) strain. As well as lacto-N-tetraose, this oligosaccharide was also obtained via the K12 strain of E.Coli that has already been approved as a novel food. (13)
Chr. Hansen A/S applied for and received its approval as a novel food, again with exclusivity, under conditions similar to those for lacto-N-tetraose. (14)
5) RECTIFICATIONS.
The Union List of Novel Foods
(ULNF) – contained in Reg. (EU) 2017/2470 as amended – has been corrected in some inaccuracies. Novel foods affected by the adjustments are:
- xylo-oligosaccharides (EU reg. 2018/1648). Specifications for xylooligosaccharides in syrup form have been supplemented with the parameter ‘dry material’,
- Sweet whey protein isolate from cow’s milk (EU reg. 2019/1686). Correspondences between food categories and uses, as well as maximum permitted levels, were clarified,
- 3′-sialyl-lactose from microbial source (EU Reg. 2021/96). Maximum levels for the category of ‘flavored fermented milk-based products, including heat-treated products‘ were mistakenly added to the food category ‘unflavored fermented milk-based products‘ and vice versa. (15)
6) Interim Conclusions
Reg. EU 2015/2283 (Novel Food Regulation) is proving its effectiveness in fostering innovation in the agribusiness sector, without ever disregarding a rigorous analysis of food safety risks.
The increasing development of research activities is also observed , including with the support of European (Horizon Europe) and Euro-Mediterranean (PRIMA) projects. Especially in the area of alternative and sustainable protein sources such as fungi, microalgae and insects.
New possible solutions are thus glimpsed to contribute to the food security and nutrition security goals agreed upon under the Sustainable Development Goals (SDGs), in UN Agenda 2030.
#SDG2, Zero Hunger. #SDG3, Ensure Health and Well-being.
Dario Dongo and Andrea Adelmo Della Penna
Cover vignette from ‘Japanese cooking with manga’ (Tuttle books, 2018) https://www.tuttlepublishing.com/japan/japanese-cooking-with-manga
Notes
(1) EFSA NDA Panel (2022). Safety of pea and rice protein fermented by Shiitake (Lentinula edodes) mycelia as a Novel food pursuant to Reg. (EU) 2015/2283. EFSA Journal 20(4):7205, https://doi.org/10.2903/j.efsa.2022.7205
(2) Reg. (EU) 2023/6, authorizing the placing on the market of pea- and rice-derived protein fermented from the mycelia of Lentinula edodes (Shiitake mushroom) as a novel food http://data.europa.eu/eli/reg_impl/2023/6/oj (effective 24.1.23)
(3) EFSA NDA Panel (2022). Safety of freeze-dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283. EFSA Journal 20(6):7380 https://doi.org/10.2903/j.efsa.2022.7380
(4) Reg. (EU) 2022/2535, authorizing the placing on the market of freeze-dried Antrodia camphorata mycelia in powder form as a novel food http://data.europa.eu/eli/reg_impl/2022/2535/oj (Entry into force 11.1.23)
(5) Commission Implementing Regulation (EU) 2023/4 of January 3, 2023 , authorizing the placing on the market of mushroom powder containing vitamin D2 as a novel food and amending Reg. (EU) 2017/2470 http://data.europa.eu/eli/reg_impl/2023/4/oj (Entry into force 24.1.23)
(6) EFSA NDA Panel (2022). Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2019/1471). EFSA Journal 20(6):7326, https://doi.org/10.2903/j.efsa.2022.7326
(7) Reg (EU) 2023/5, authorizing the placing on the market of partially defatted powder of Acheta domesticus (house cricket) as a novel food http://data.europa.eu/eli/reg_impl/2023/5/oj (entry into force 24.1.23)
(8) Reg. (EU) 2023/58, authorizing the placing on the market of Alphitobius diaperinus (lesser mealworm) larvae frozen, paste, dried and powdered as a novel food http://data.europa.eu/eli/reg_impl/2023/58/oj (Entry into force 26.1.23)
(9) EFSA NDA Panel (2022). Safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 20(4):7204 https://doi.org/10.2903/j.efsa.2022.7204
(10) Commission Implementing Regulation (EU) 2022/2534 of December 21, 2022 , authorizing the placing on the market of beta-lactoglobulin (β-lactoglobulin) from cow’s milk as a novel food http://data.europa.eu/eli/reg_impl/2022/2534/oj (Entry into force 11.1.23)
(11) EFSA NDA Panel (2022). Safety of lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSA Journal 20(5):7242, https://doi.org/10.2903/j.efsa.2022.7242
(12) Reg (EU) 2023/7 authorizing the placing on the market of lacto-N-tetraose produced from derived strains of Escherichia coli BL21 (DE3) as a novel food http://data.europa.eu/eli/reg_impl/2023/7/oj (effective 24.1.23)
(13) EFSA NDA Panel (2022). Safety of 3-fucosyllactose (3-FL) produced by derivative strains of Escherichia coli BL21 (DE3) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSA Journal 20(5):7329, https://doi.org/10.2903/j.efsa.2022.7329
(14) Reg. (EU) 2023/52 authorizing the placing on the market of 3-fucosyllactose produced by a derived strain of Escherichia coli BL21(DE3) as a novel food http://data.europa.eu/eli/reg_impl/2023/52/oj (effective 25.1.23)
(15) Reg. (EU) 2023/65 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Implementing Regulation (EU) 2018/1648 authorizing the placing on the market of xylo-oligosaccharides as a novel food, of Implementing Regulation (EU) 2019/1686 authorizing an extension of use of sweet whey protein isolate from cow’s milk as a novel food, and of Implementing Regulation (EU) 2021/96 authorizing the placing on the market of 3′-sialyl lactose sodium salt as a novel food http://data.europa.eu/eli/reg_impl/2023/65/oj (effective 29.1.23)
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
